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Toronto-based, University Health Network (UHN) start-up company, MolecuLight® Inc. announced today that it has achieved a key regulatory milestone by receiving FDA's De Novo clearance for a first-of-its-kind handheld fluorescence imaging device, the MolecuLight i:X.

The MolecuLight i:X device captures and documents digital fluorescence information from wounds and tissue surrounding the wound site with real time videos and still images. This point-of-care device has been optimized to be portable, compact, and eliminates the use of contrast agents.

MolecuLight® Inc., will now be able to provide the MolecuLight i:X as a prescription-use only point-of-care imaging device to clinicians in the USA. In turn, clinicians will gain a much needed tool to make improved decisions about the diagnosis and treatment of patients' dermal wounds when the wound sites are exposed to excitation light.

The MolecuLight i:X device has already received the Health Canada Medical Device License (2015) and the European CE Mark (2016). With FDA's marketing authorization, MolecuLight® Inc., continues its global expansion of its initial flagship product and accessories.